Medication info

Egesta Tablet 3mg (Eszopiclone)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Eszopiclone›3mg / 1 tablet
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
Blue round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202203438 · Approved 2022.08.31

This product's status changed to Approval withdrawn on 2024.03.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of insomnia
Who takes it
Adults
Adult dose
Use the lowest effective dose of this medicine. The recommended daily dose for adults is 1mg. If clinically necessary, the dose may be increased to 2-3mg. Because this medicine may impair driving or other activities requiring full alertness the following day, take it once immediately before bedtime, allowing at least 7-8 hours between taking the medicine and waking. Do not exceed the recommended dose of 3mg; take once immediately before bedtime. For elderly or debilitated patients, do not exceed 2mg daily. For patients with severe hepatic impairment or those taking a strong CYP3A4 inhibitor, do not exceed 2mg daily (see Interactions). For patients taking central nervous system depressants, dosage adjustment may be necessary because of the possibility of additive effects. Taking this medicine with or immediately after a high-fat/high-calorie meal is expected to slow its absorption and reduce its effect on sleep latency.

Ingredients

Manufacturer
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of insomnia

  • Insomnia
View approved original text

This medication is used for insomnia.

How to take

Adult dose

Use the lowest effective dose of this medicine. The recommended daily dose for adults is 1mg. If clinically necessary, the dose may be increased to 2-3mg. Because this medicine may impair driving or other activities requiring full alertness the following day, take it once immediately before bedtime, allowing at least 7-8 hours between taking the medicine and waking. Do not exceed the recommended dose of 3mg; take once immediately before bedtime. For elderly or debilitated patients, do not exceed 2mg daily. For patients with severe hepatic impairment or those taking a strong CYP3A4 inhibitor, do not exceed 2mg daily (see Interactions). For patients taking central nervous system depressants, dosage adjustment may be necessary because of the possibility of additive effects. Taking this medicine with or immediately after a high-fat/high-calorie meal is expected to slow its absorption and reduce its effect on sleep latency.

Precautions

This medication has a central nervous system depressant effect, so caution is required when driving or performing hazardous activities the next day after use. Particularly, using in high doses or in combination with other central nervous system depressants or alcohol may enhance these effects. Moreover, while this medication is used to treat sleep disorders, if symptoms do not improve after taking it for more than 7-10 days, a professional assessment is needed as there may be other physical or mental disorders. Rarely, anaphylactic reactions causing swelling of the tongue, vocal cords, and larynx may occur during the use of this medication, and if such symptoms arise, the medication should be stopped immediately. Abnormal thoughts and behavioral changes such as aggression, hallucinations, and abnormal behavior during sleep may occur, and if these symptoms arise, the medication should be discontinued, and the physician should be consulted. This medication has potential for abuse and dependence; therefore, it should be used carefully, particularly in patients with a history of substance abuse or psychiatric conditions. The medication must be taken immediately before bedtime, and taking it while awake can lead to side effects such as amnesia, hallucinations, and dizziness. This medication should not be used in specific patients such as those under 18 years of age, those with acute respiratory failure, or those with lactose intolerance. Elderly patients or those who are weakened may be more sensitive to the medication, so dosage should be reduced and closely monitored. Dosage adjustment may be necessary for patients with liver impairment or those taking CYP3A4 inhibitors, and caution is also advised for patients with depression. The safety of this medication has not been established during pregnancy or breastfeeding, so it should be used only after consulting with a professional. In the case of overdose, central nervous system depressant symptoms may appear, and immediate treatment is required in emergency situations. Lastly, this medication should be stored out of the reach of children and kept in its original container.

Side effects

  • Headache
  • viral infection
  • dry mouth
  • dyspepsia
  • nausea
  • vomiting
  • anxiety
  • confusion
  • depression
  • dizziness
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  • hallucinations
  • decreased libido
  • irritability
  • drowsiness
  • infection
  • rash
  • unpleasant taste
  • dysmenorrhea
  • gynecomastia
  • accidental injury
  • pain
  • diarrhea
  • abnormal dreams
  • pruritus
  • urinary tract infection
  • chest pain
  • allergic reaction
  • cellulitis
  • facial swelling
  • fever
  • halitosis
  • heat stroke
  • hernia
  • discomfort
  • neck stiffness
  • photophobia
  • migraine
  • hypertension
  • thrombophlebitis
  • anorexia
  • cholelithiasis
  • increased appetite
  • hematochezia
  • oral ulcer
  • thirst
  • aphthous stomatitis
  • colitis
  • dysphagia
  • gastritis
  • hepatitis
  • hepatomegaly
  • liver damage
  • gastric ulcer
  • stomatitis
  • edema of the tongue
  • rectal bleeding
  • anemia
  • lymphadenopathy
  • peripheral edema
  • hypercholesterolemia
  • weight gain
  • weight loss
  • dehydration
  • gout
  • hyperlipidemia
  • hypokalemia
  • arthritis
  • bursitis
  • joint disease
  • leg cramps
  • myasthenia gravis
  • convulsions
  • osteoarthritis
  • myopathy
  • ptosis
  • coughing
  • numbness
  • ataxia
  • emotional instability
  • hostility
  • hypertonicity
  • sensory deprivation
  • ataxia
  • insomnia
  • memory impairment
  • neurosis
  • nystagmus
  • perceptual disorder
  • decreased reflexes
  • abnormal thinking
  • dizziness
  • abnormal gait
  • euphoria
  • hypersensitivity
  • hypokinesia
  • neuritis
  • neurological disorders
  • altered consciousness
  • tremors
  • asthma
  • bronchitis
  • dyspnea
  • epistaxis
  • hiccups
  • laryngitis
  • acne
  • alopecia
  • contact dermatitis
  • dry skin
  • eczema
  • skin discoloration
  • sweating
  • urticaria
  • erythema multiforme
  • myxedema
  • herpes zoster
  • hypertrichosis
  • granuloma annulare
  • pityriasis rosea
  • conjunctivitis
  • dry eyes
  • ear pain
  • external otitis
  • otitis media
  • tinnitus
  • vestibular dysfunction
  • auditory hyperesthesia
  • iritis
  • mydriasis
  • photophobia
  • amenorrhea
  • mastitis
  • breast enlargement
  • breast tumor
  • breast pain
  • cystitis
  • bladder dysfunction
  • female lactation
  • hematuria
  • nephrolithiasis
  • kidney pain
  • galactophoritis
  • menorrhagia
  • uterine bleeding
  • urinary frequency
  • incontinence
  • uterine bleeding
  • vaginal bleeding
  • vaginitis
  • oliguria
  • pyelonephritis
  • urethritis
  • olfactory dysfunction

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius to ensure the efficacy and safety of the medication for an extended period.

Appearance and packaging

Appearance

Blue round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.